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Approved Drug Products containing 20648 listed in the FDA Orange Book. Original Data : FDA Website

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01 BAUSCH (7)

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01 GEL;RECTAL (7)

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01 DISCN (4)

02 RX (3)

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01 DIASTAT (5)

02 DIASTAT ACUDIAL (2)

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01 Yes (7)

URL Supplier Web Content
GEL; RECTAL
20MG/4ML (5MG/ML)
2005-09-15
20648
DIASTAT ACUDIAL
RX
Yes
AB
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GEL; RECTAL
15MG/3ML (5MG/ML) ...
1997-07-29
20648
DIASTAT
DISCN
Yes
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GEL; RECTAL
5MG/ML (5MG/ML) **...
1997-07-29
20648
DIASTAT
DISCN
Yes
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GEL; RECTAL
10MG/2ML (5MG/ML)
2005-09-15
20648
DIASTAT ACUDIAL
RX
Yes
AB
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GEL; RECTAL
20MG/4ML (5MG/ML) ...
1997-07-29
20648
DIASTAT
DISCN
Yes
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URL Supplier Web Content
GEL; RECTAL
10MG/2ML (5MG/ML) ...
1997-07-29
20648
DIASTAT
DISCN
Yes
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GEL; RECTAL
2.5MG/0.5ML (5MG/M...
1997-07-29
20648
DIASTAT
RX
Yes
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Looking for FDA Orange Book APPLICATION 20648

Looking for FDA Orange Book APPLICATION 20648 7

19

Bausch & Lomb Incorporated, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIAZEPAM, with a corresponding application number 20648.

Regulatory Information RX

With a dosage strength 20MG/4ML (5MG/ML)

Dosage Form Route GEL; RECTAL

Reference Listed Drug Yes

Approved since 2005-09-15

Therapeutic Equivalence (TE) Code AB

18

Bausch & Lomb Incorporated, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIAZEPAM, with a corresponding application number 20648.

Regulatory Information DISCN

With a dosage strength 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route GEL; RECTAL

Reference Listed Drug Yes

Approved since 1997-07-29

17

Bausch & Lomb Incorporated, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIAZEPAM, with a corresponding application number 20648.

Regulatory Information DISCN

With a dosage strength 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route GEL; RECTAL

Reference Listed Drug Yes

Approved since 1997-07-29

16

Bausch & Lomb Incorporated, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIAZEPAM, with a corresponding application number 20648.

Regulatory Information RX

With a dosage strength 10MG/2ML (5MG/ML)

Dosage Form Route GEL; RECTAL

Reference Listed Drug Yes

Approved since 2005-09-15

Therapeutic Equivalence (TE) Code AB

15

Bausch & Lomb Incorporated, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIAZEPAM, with a corresponding application number 20648.

Regulatory Information DISCN

With a dosage strength 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route GEL; RECTAL

Reference Listed Drug Yes

Approved since 1997-07-29

14

Bausch & Lomb Incorporated, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIAZEPAM, with a corresponding application number 20648.

Regulatory Information DISCN

With a dosage strength 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route GEL; RECTAL

Reference Listed Drug Yes

Approved since 1997-07-29

13

Bausch & Lomb Incorporated, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is DIAZEPAM, with a corresponding application number 20648.

Regulatory Information RX

With a dosage strength 2.5MG/0.5ML (5MG/ML)

Dosage Form Route GEL; RECTAL

Reference Listed Drug Yes

Approved since 1997-07-29

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